• A clear sense of the mission of the regulatory authority is important in motivating DRA staff to pursue regulatory processes in order to achieve drug regulation. Governments should state clearly the mission and objectives of drug regulation, so that the attainment of the intended objectives can be easily assessed.
• Drug laws should be sufficiently comprehensive, covering all activities involving drug products and information, and updated regularly.
• One central agency should be accountable for the overall effectiveness of drug regulation.
• Personnel engaged in drug regulation should be individuals of integrity and appropriately trained and qualified. Human resources development programmes should be made available to help staff to improve their knowledge and skills and to enable them to cope with developments in pharmaceutical science and technology. They should also have access to the latest scientific and technological information to facilitate their work.
• Appropriate standards and guidelines should be developed and used as tools for the application of all regulatory processes. They should be freely available to all stakeholders, including the public, in order to increase the transparency of the DRA’s operations. The same standard of regulation should be applied to all drugs, whether they are imported and/or manufactured by the public or the private sector, and destined for domestic consumption or for export.
• Sustainable financing is essential to promote effective drug regulation. Drug regulatory authority financing should strike a balance between fees covering the full cost of services and government support. Fees should provide increased revenue to the authority so that it can perform effectively, and serve to discourage clients from “flooding” the system with applications that do not meet official requirements.
• Every regulatory function contributes to ensuring the safety quality and efficacy of drugs. The action taken by the authority should cover all drug regulatory functions in a balanced fashion. Support for drug regulation should not be compromised by other non-regulatory tasks with which the DRA may also be charged.
• The regulatory process should be systematically monitored in order to identify problems and determine whether actual activities match the intended actions. Moreover, the DRA should become a learning organization which routinely conducts self-assessment and continuous quality improvement. There should be administrative and legislative supervision in order to guarantee accountability. Peer review by drug regulatory authorities in other countries can serve as a means of external auditing, whereby the performance of one agency can be compared with that of its peers.
• Any inefficiency in the regulatory process delays decision-making and may lead to shortages of critically needed drugs, thus endangering human lives. Drug regulatory authorities should employ various strategies to increase efficiency of resource use, e.g. prioritization and streamlining of the work process; job enlargement and job enrichment for regulatory staff; pooling of international information resources; and sharing and pooling of international QC resources.
• Drug regulatory authorities should communicate regularly with their clients. They should also acknowledge the right of citizens to be provided with accurate and appropriate information on drugs marketed in their country. Educating citizens about the efficacy, safety, quality and rational use of drugs will ultimately enhance the achievement of regulatory objectives.
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